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Daphne freeze-drying powder injection and its preparation method

A freeze-dried powder injection and injection technology, which is applied in the field of pharmaceutical preparations, can solve the problems of easy mold, difficult storage, and poor stability, and achieve the effects of easy storage, clarity, and stability

Inactive Publication Date: 2008-02-13
ZHUHAI TONGYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Tablet dripping pills contain starch and / or hard acid and other substances. These substances are prone to mold and are not easy to store in an environment with high humidity and high temperature. Moreover, tablets and dropping pills are administered orally and absorbed by the stomach. , the effect is slow, the injection is given by injection, and the effect is fast, but its stability is poor and it is not easy to store

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A kind of zushima freeze-dried powder injection of the present embodiment uses 1000 grams of zushima root bark and its stem bark as raw materials, and the extract obtained by single diafiltration is filtered, and the ethanol is recovered by distillation under reduced pressure, and then added Dilute with sterile water for injection or concentrate under reduced pressure to the equivalent of 1 g of Zushima root bark and stem bark per milliliter of solution, refrigerate, filter, adjust the pH to 3.5, refrigerate, filter, then adjust the pH to 1.5, reflux, and adjust the pH again To 7, add active carbon for injection, add mannitol, make the solution contain mannitol 50mg / ml, filter, and then freeze-dry to form Zushima lyophilized powder injection.

[0044] A preparation method of zushima freeze-dried powder for injection of the present embodiment comprises the following steps:

[0045] (1) Get the root bark and stem bark dry raw material of 1000 grams of Zushima, carry out p...

Embodiment 2

[0050] The operation method and the equipment used in this embodiment are basically the same as in Example 1, the only difference is that the root bark and stem bark of 500 grams of Zushima are used as raw materials, and the extract is obtained by single diafiltration, filtered, and recovered by distillation under reduced pressure After ethanol, add sterilized water for injection to dilute or concentrate under reduced pressure to a solution equivalent to 0.5 grams of Zushima root bark and stem bark per milliliter of solution, refrigerate, filter, adjust the pH to 3.0, refrigerate, filter, and then adjust the pH to 1.2 , reflux, adjust the pH to 6.5, add activated carbon for injection, add mannitol, make the solution contain mannitol 100mg / ml, filter, freeze-dry to form Zushima freeze-dried powder injection.

[0051] Its preparation method is:

[0052] (1) Take 500 grams of Zushi hemp root bark and stem bark dry raw materials, grind the Zushi hemp root bark and stem bark dry ra...

Embodiment 3

[0057] The operating method and the equipment used in this embodiment are basically the same as in Example 1, except that the root bark of 1500 grams of Zushima and its stem bark are used as raw materials, and the extract obtained by the single diafiltration method is filtered and decompressed. After distilling and recovering ethanol, add sterilized water for injection to dilute or concentrate under reduced pressure to a solution equivalent to 1.5 grams of Zushima root bark and stem bark per milliliter, refrigerate, filter, adjust the pH to 4.0, refrigerate, filter, and then adjust the pH to 1.7, reflux, adjust the pH to 7.5, add activated carbon for injection, add mannitol, make the solution contain mannitol 200mg / ml, filter, and freeze-dry to form Zushima lyophilized powder injection.

[0058] Its preparation method is:

[0059](1) Take 1500 grams of dry root bark and stem bark of Zushima, crush the dry raw materials of Zushima root bark and stem bark into the medium powder ...

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PUM

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Abstract

The present invention relates to freeze dried powder for injection prepared with the extract of root bark and stem bark of girald daphne. The preparation process is used in treating gall, stabbing pain, psychroalgia, etc. of limbs and trunk. It is prepared through a percolation process including extracting barked root and stem of girald daphne, filtering, decompression distillation to concentrate while recovering alcohol, re-filtering, regulating pH to 6.5-7.5 and resulting in mannitol concentration in the solution of 50-200mg / ml, filtering for the third time, and freeze drying. The freeze dried powder for injection has high curative effect and fast acting, and the low temperature vacuum drying process avoids the decomposition and oxidation of effective medicine components and results in high medicine stability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation made from extracts of plant materials and a preparation method thereof, more specifically to a freeze-dried powder injection made from extracts of root bark and stem bark of zushima and a preparation method thereof. Background technique [0002] The chemical name of Daphnetin is 7,8-dihydroxycoumarin (7,8-dihydoxycoumarin), which is the active ingredient in the root bark and stem bark of Zushima, which has the functions of expelling wind and dampness, promoting blood circulation and relieving pain. Dilate coronary vessels, increase coronary blood flow, reduce cardiac oxygen consumption, improve myocardial metabolism, and promote cardiac function recovery. [0003] Chinese patent document application number 93104946.0, open date 1994.11.9, publication number is CN1094627A reported Zushima tablet and preparation method thereof, Zushima tablet composition formula is Zushima extract (equivalent to metha...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/83A61K9/19A61P9/10A61K125/00A61K129/00
Inventor 丁钉生
Owner ZHUHAI TONGYUAN PHARMA CO LTD